NCT07128628

A Study Evaluating the Safety and Efficacy of a Fixed-Dose Combination for Dry Eye Disease

A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 423 (estimated)
• Sponsor: Bausch & Lomb Incorporated · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A 4-Week, Randomized, Double-Masked, Parallel-Group, Active-Controlled, Multicenter Study Evaluating Lifitegrast/Perfluorohexyloctane Fixed-Dose Combination Administered Twice Daily on Signs and Symptoms of Dry Eye Disease

Conditions

• Dry Eye Disease

Interventions

Type	Name	Description
DRUG	Lifitegrast/Perfluorohexyloctane Fixed Dose Combination	Topical ocular drop of lifitegrast and perfluorohexyloctane administered for 4 weeks
DRUG	Lifitegrast	Topical ocular drop of lifitegrast administered for 4 weeks
DRUG	Perfluorohexyloctane	Topical ocular drop of perfluorohexyloctane administered for 4 weeks
DRUG	Vehicle	Topical ocular drop with no active ingredients administered for 4 weeks
DRUG	Vehicle	Topical ocular drop with no active ingredients administered for 4 weeks
DRUG	Vehicle	Topical ocular drop with no active ingredients administered for 4 weeks

Timeline

• Start date: 2025-10-24
• Primary completion: 2026-11-01
• Completion: 2026-11-01
• First posted: 2025-08-19
• Last updated: 2026-03-13

Locations

32 sites across 1 country: United States

Regulatory

• FDA-regulated drug study